First topical therapy approved for treatment of ED, characterized by ease of use, rapid onset and high tolerability

Launch in Sandoz’s largest EU market further demonstrates company commitment to meeting unmet medical need across key therapeutic areas

Holzkirchen, August 18, 2014 - Sandoz, the generic pharmaceuticals division of Novartis, today announces the launch in Germany of Vitaros®, an innovative new topical therapy for erectile dysfunction (ED), one of the leading urological disorders in Europe and worldwide. Earlier this month, Sandoz launched Vitaros in Sweden.

“This launch demonstrates Sandoz’s commitment to finding novel and innovative ways to meet patient need across a wide range of therapeutic areas,” said Nick Haggar, Sandoz Head of Western Europe, Middle East & Africa.

He added: “Vitaros® is the first topical ED therapy to be made available to patients in Europe and the first novel ED treatment in nearly a decade. It is characterized by its ease of use, rapid onset and high tolerability.”

Edward D. Kim, M.D., of the University of Tennessee Graduate School of Medicine in Knoxville, said: “Vitaros® may have a significant effect on the care of patients who are either unresponsive to or contraindicated for the current treatment paradigm.”

Vitaros®, developed by Apricus Biosciences, contains the active pharmaceutical ingredient alprostadil. It has been licensed to Sandoz by Apricus for commercialization in Sweden, Germany and nine other Western European countries.

According to IMS Health, the ED market in Europe was worth more than USD 1.3 billion as of December 2013, based on prescription sales. The German ED market was estimated to be worth more than USD 150 million.

About Sandoz

Sandoz, the generic pharmaceuticals division of Novartis, is a global leader in the generic pharmaceutical sector. Sandoz employs over 26,500 employees and its products are available in more than 160 countries, offering a broad range of high-quality, affordable products that are no longer protected by patents. With USD 9.2 billion in sales in 2013, Sandoz has a portfolio of approximately 1,100 molecules, and holds the #1 position globally in biosimilars as well as in generic injectables, ophthalmics, dermatology and antibiotics, complemented by leading positions in the cardiovascular, metabolism, central nervous system, pain, gastrointestinal, respiratory, and hormonal therapeutic areas. Sandoz develops, produces, and markets these medicines, as well as active pharmaceutical and biotechnological substances. Nearly half of Sandoz's portfolio is in differentiated products, which are defined as products that are more difficult to scientifically develop and manufacture than standard generics.

In addition to strong organic growth since consolidating its generics businesses under the Sandoz brand name in 2003, Sandoz has benefitted from strong growth of its acquisitions, which include Lek (Slovenia), Sabex (Canada), Hexal (Germany), Eon Labs (US), EBEWE Pharma (Austria), Oriel Therapeutics (US), and Fougera Pharmaceuticals (US).